NanoViricides announced that the Congolese regulatory authority, the Autorité Congolaise de Réglementation Pharmaceutique (ACOREP), has granted approval to initiate a Phase II clinical trial of its lead antiviral candidate NV‑387 for the treatment of monkeypox (MPox) in the Democratic Republic of Congo (DRC). The approval, disclosed on November 10 2025, follows a prior ethics committee clearance from CNES in May 2025 and allows the company to begin recruiting hospitalized MPox patients in the DRC.
The planned study will enroll 80 patients and is structured in two parts: a Phase 2a safety and dose‑finding phase and a Phase 2b efficacy phase that compares standard of care (SOC) alone to SOC plus NV‑387. The trial will assess safety, tolerability, and antiviral activity, with endpoints that include viral load reduction and clinical recovery time. The DRC’s high MPox incidence, including a severe Clade I strain, makes it a critical setting for evaluating a broad‑spectrum antiviral.
NanoViricides’ financial position underscores the importance of this regulatory milestone. As of June 30 2025, the company held approximately $1.67 million in cash and cash equivalents and had used $8.48 million in operating cash outflows for the fiscal year. The company’s earnings per share remain negative and its Piotroski F‑Score is low, indicating limited financial runway. Successful completion of the Phase II trial could open pathways to additional funding or partnership opportunities, which are essential for advancing NV‑387 toward commercialization.
The MPox treatment market is expanding rapidly. Estimates project a global market of $200 million to $1 billion by 2030, driven by ongoing outbreaks in Africa and the need for effective therapeutics. Current options are limited to tecovirimat and brincidofovir, with tecovirimat trials showing mixed efficacy. NV‑387’s host‑mimetic nanomedicine platform offers a novel mechanism that may overcome resistance and provide broader antiviral coverage, positioning it as a potentially disruptive candidate in this niche market.
NV‑387 is engineered to mimic host cell receptors, enabling it to bind and neutralize enveloped viruses. Preclinical studies in animal models have shown efficacy comparable to tecovirimat for smallpox and enhanced survival when combined with tecovirimat. Phase I human trials reported no adverse events and demonstrated a favorable safety profile, supporting progression to Phase II. The broad‑spectrum potential of NV‑387 also extends to RSV, COVID‑19, influenza, and other viral infections, which could amplify its commercial value if the MPox trial succeeds.
President and Executive Chairman Anil R. Diwan emphasized that the ACOREP approval is a “critical milestone” that validates the company’s platform and accelerates its path to market. He noted that while the company faces financial constraints, the regulatory clearance provides a tangible step toward securing additional capital and advancing NV‑387 toward a potential MPox treatment that could address an unmet medical need in the DRC and beyond.
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